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Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00824161
Recruitment Status : Terminated
First Posted : January 16, 2009
Results First Posted : August 17, 2011
Last Update Posted : April 23, 2012
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109

Condition or disease Intervention/treatment Phase
Advanced Colorectal Cancer Drug: TAS-109 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer
Study Start Date : January 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: 1
Drug: TAS-109

14-day continuous central intravenous infusion at a dose of 2.0 mg/m2/day followed by a 7-day rest period.

Number of cycles: until unacceptable toxicity or disease progression requires discontinuation.

Primary Outcome Measures :
  1. Percentage of Progression Free Survival [ Time Frame: From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months. ]
    The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.

Secondary Outcome Measures :
  1. Antitumor Activity [ Time Frame: From the date of initial treatment until the date of the first objective documentation of PD or death from any cause. ]
    Per RECIST Criteria and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response rate was defined as percentage of patients of CR plus PR in ITT population.

  2. Overall Survival [ Time Frame: From the initial treatment until 12 months after enrollment of the last patient. ]
    Overall survival is defined as the period from the date of first dose of TAS-109 to death date.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed colorectal adenocarcinoma
  • Received prior therapy, at least two regimens, containing a fluoropyrimidine, oxaliplatin, and irinotecan
  • Have at least one measurable tumor, as defined by RECIST
  • Must be capable of maintaining a central venous line access

Exclusion Criteria:

  • Had previous anti-tumor therapy in the 3 weeks prior to study entry
  • Have not recovered from all toxicities (excluding alopecia) from prior therapy to baseline or ≤grade 1 prior to study entry
  • Have another malignancy in the past 3 years except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00824161

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United States, New York
NYU Cancer Institute
East 34th Street, New York, New York, United States, NY 10016
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Holcombe Boulevard, Houston, Texas, United States, TX 77030
The Center for Cancer and Blood Disorders
West Magnolia Avenue, Fort Worth, Texas, United States, TX 76104
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
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Principal Investigator: Henry Xiong, M.D., Ph.D. The Center for Cancer and Blood Disorders

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Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00824161    
Other Study ID Numbers: TAS109-0403
First Posted: January 16, 2009    Key Record Dates
Results First Posted: August 17, 2011
Last Update Posted: April 23, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases